Home / 510(k) Clearances / K090625

510(k) K090625

WIRELESS PORTABLE DETECTOR FD-W17 by Philips Medical Systems North America Co. — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2009
Date Received
March 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Philips Medical Systems North America Co.

  • K101311 — EP NAVIGATOR R3 (September 30, 2010)
  • K102005 — ALLURA XPER OR TABLE SERIES (August 9, 2010)
  • K090590 — VERADIUS, MODEL 718-130 (March 16, 2009)
  • K082280 — SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 (October 8, 2008)
  • K063781 — PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE (January 5, 2007)
  • K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR (November 22, 2006)
  • K062268 — MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A0 (October 18, 2006)
  • K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MO (September 20, 2006)
  • K061685 — PULSERA (September 15, 2006)
  • K061995 — XCELERA (September 6, 2006)

Other clearances for product code MQB

  • K252911 — Lux HD 2530 detector (Lux HD 2530) (October 9, 2025)
  • K250211 — Yushan X-Ray Flat Panel Detector (July 22, 2025)
  • K250665 — SKR 3000 (June 17, 2025)
  • K243734 — Wireless/ Wired X-Ray Flat Panel Detectors (April 18, 2025)
  • K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (March 20, 2025)
  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
  • K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (March 18, 2025)
  • K244010 — ExamVue Apex (February 24, 2025)
  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)